Weight Management

Setmelanotide

Imcivree · RM-493 · MC4R agonist

Setmelanotide (Imcivree) is a hyper-expensive, ultra-selective MC4R receptor agonist representing the absolute pinnacle of precision genetic medicine. FDA-approved exclusively for patients with catastrophic underlying genetic mutations (POMC, PCSK1, or LEPR deficiencies), it bypasses the body’s broken metabolic hardware to manually "turn off" the starvation signal in patients who otherwise suffer from incurable, literally endless hyperphagia (extreme hunger).

Not FDA-approved - research chemical
Reviewed by CalcMyPeptide Editorial Team
Last updated: August 2026Evidence: High1 peer-reviewed citation
Typical research dose
1-3 mg/day
Frequency
1× daily
Half-life
11-12 hours
Common vials
10 mg
CAS
920014-72-8
Molecular weight
1117.3 g/mol

Use-case scores

0–10 against the evidence we have, not a gym ranking. Hidden domains do not apply here.

  • Metabolic / weight7/10

    Imcivree is FDA-approved for POMC/PCSK1/LEPR deficiency obesity. Ceiling 9; haircut because a research cake is not Imcivree and common obesity is not those genotypes.

Compound card

Class
MC4R agonist (Imcivree; labeled rare genetic obesity)
Formula
C49H68N18O9S2
Status
Not FDA-approved · research use
Dose it
10 mg + 2 mL BAC water → 5 mg/mL · 1000 mcg ≈ 20 units (U-100)
Open in calculator

How it works

Setmelanotide (Imcivree®) is a melanocortin-4 receptor (MC4R) agonist developed specifically for rare genetic obesity disorders caused by deficiencies in the leptin-melanocortin pathway. It directly activates MC4R in the hypothalamus to restore satiety signaling that is absent or blunted in patients with loss-of-function mutations in POMC (pro-opiomelanocortin), PCSK1 (proprotein convertase subtilisin/kexin type 1), LEPR (leptin receptor), BBS (Bardet-Biedl syndrome), or Alström syndrome genes. FDA breakthrough therapy approval in 2020. Clinical trials show 25%+ weight loss in genetically confirmed patients.

Source: PMID: 32320060 (Phase 3 NEJM)

Research Use Cases

  • ✓Genetic Obesity Syndromes: High

Dosing

PhaseDoseFrequencyNotes
Pediatric (≥6 years)1 mg/day → titrate to 3 mg/dayOnce daily SC (morning)Start at 1 mg/day. Increase by 0.5 mg every 2 weeks based on response.
Adult2 mg/day → titrate to 3 mg/dayOnce daily SC (morning)FDA-approved for BBS, Alström, POMC, PCSK1, LEPR deficiency.

Administration

Route / form
Subcutaneous injection (abdomen)
Timing
Once daily in the morning.
Empty stomach?
No - Food timing is not critical.

Timeline

Month 1-3
Hunger reduction often dramatic in genetically affected patients. Early weight loss.
Month 6-12
Average >25% body weight reduction in clinical trials for POMC/LEPR deficiency.

Who it is for

Genetic Obesity Syndromes

High

FDA-approved for POMC, PCSK1, LEPR deficiency and BBS/Alström syndrome. First targeted treatment for these patients.

Reconstitution

VialWaterConcentrationExample dose
10 mg lyophilized2 mL BAC5 mg/mLLabeled product is a multi-dose vial with its own insert. Research cakes are not Imcivree.

Change vial size or water volume? Open the reconstitution calculator.

Safety & Considerations

FDA-approved (Imcivree). NOT for general obesity - only for confirmed MC4R pathway genetic deficiencies. Side effects: hyperpigmentation (MC1R off-target), injection site reactions, sexual adverse events. Genetic testing required before prescribing.

Regulatory & Legal Status

FDA Status (US)
Research Only
WADA Status (2026)
Not Listed

Not currently on the WADA 2026 Prohibited List. Policies may change - verify before competition.

Classification

Research Chemical

US Compounding: Not eligible / not available

⚠️ This information is for educational purposes only and may not reflect the most current regulatory updates. Always verify with official FDA, WADA, and jurisdiction-specific sources before use.

Limits of current evidence

  • Genotype-restricted label. BMI-alone is the wrong patient.
  • Hyperpigmentation is on-mechanism.

Verdict

Setmelanotide is Imcivree for rare MC4R-pathway genetic obesity. It is not Wegovy and not MT-2. Do not use it as a general weight-loss research peptide.

Interactions & Contraindications

FDA-approved (Imcivree). NOT for general obesity - only for confirmed MC4R pathway genetic deficiencies. Side effects: hyperpigmentation (MC1R off-target), injection site reactions, sexual adverse events. Genetic testing required before prescribing.

Frequently Asked Questions

Can setmelanotide be used for general obesity?▼
No - setmelanotide is a targeted therapy for specific rare genetic mutations in the leptin-melanocortin (MC4R) pathway. It is ineffective and not approved for common obesity without these mutations.
What genetic conditions qualify for setmelanotide?▼
FDA-approved for: POMC deficiency, PCSK1 deficiency, LEPR deficiency, Bardet-Biedl syndrome (BBS), and Alström syndrome. Genetic testing must confirm the mutation before starting therapy.

References

  1. Clément K et al. “"Setmelanotide for obesity due to POMC or LEPR deficiency (Phase 3)".” New England Journal of Medicine (2020). PMID: 33086009

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